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Synthetic Oligonucleotides: Regulatory, Analytical & Manufacturing Considerations
By Maura Kibbey, Ph.D., and Nick Healy, U.S. Pharmacopeia (USP)
After decades of investment, research, and development, the therapeutic value of oligonucleotides has started to materialize. Dozens of developers now have dedicated pipelines for diverse indications such as oncology, central nervous system diseases, cardiometabolic disorders, liver diseases, and viral infections, including COVID-19. A search for “oligonucleotide” on ClinicalTrials.gov returned more than 50 active studies. Advances in analytical methods are helping to support these pipelines.
Across the development and release landscapes, methods continue to refine, streamline, and support the development of oligonucleotides from new applications of nuclear magnetic resonance (NMR) spectroscopy that are pushing the boundaries of what can be accomplished in development, to innovative platform approaches for specification and release t